Co-Administration of Proton Pump Inhibitors May Negatively Affect the Outcome in Inflammatory Bowel Disease Treated with Vedolizumab

Abstract

Concomitant medications may alter the effect of biological therapy in inflammatory bowel disease. The aim was to investigate the effect of proton pump inhibitors on remission rates in patients with inflammatory bowel disease treated with the gut-selective vedolizumab. Patients from the Hungarian nationwide, multicenter vedolizumab cohort were selected for post hoc analysis. Primary outcomes were the assessment of clinical response and endoscopic and clinical remission at weeks 14 and 54. Secondary outcomes were the evaluation of the combined effect of concomitant steroid therapy and other factors, such as smoking, on remission. A total of 108 patients were identified with proton pump inhibitor data from 240 patients in the original cohort. Patients on steroids without proton pump inhibitors were more likely to have a clinical response at week 14 than patients on concomitant PPI (95% vs. 67%, p = 0.005). Non-smokers with IBD treated with VDZ were more likely to develop a clinical response at week 14 than smokers, particularly those not receiving PPI compared with patients on co-administered PPI therapy (81% vs. 53%, p = 0.041, and 92% vs. 74%, p = 0.029, respectively). We found that the use of PPIs in patients treated with VDZ may impair the achievement of response in certain subgroups. Unnecessary PPI prescriptions should be avoided.

Keywords: inflammatory bowel disease; proton pump inhibitor; vedolizumab.

Figure 1

Flow chart of patient selection. VDZ: vedolizumab; PPI: proton pump inhibitor; CDAI: Crohn’s disease activity index; SES-CD: Simple Endoscopic Score for Crohn’s Disease.

Figure 2

Representativeness analyses of enrolled patients (n = 108) compared to the entire cohort (n = 240). Gender distribution (A); age distribution in males and females (B); proportion of patients with ulcerative colitis and Crohn’s disease (C).

Figure 3

Main results of clinical response and clinical and endoscopic remission between proton pump inhibitor users and non-users during vedolizumab therapy: (a,b) clinical response at weeks 14 and 54 in PPI users vs. non-users; (c,d) clinical remission at weeks 14 and 54 in PPI users vs. non-users; (e,f) endoscopic remission at weeks 14 and 54 in PPI users vs. non-users.

Figure 4

Clinical response and clinical and endoscopic remission outcomes among proton pump inhibitor users and non-users during vedolizumab therapy in Crohn’s disease and ulcerative colitis: (a,b) clinical response in CD and UC groups with and without the use of PPI; (c,d) clinical remission in CD and UC groups with and without the use of PPI; (e,f) endoscopic remission in CD and UC groups with and without the use of PPI; black bar: patients without PPI; grey bar: patients with PPI.

Figure 5

Effect of smoking in clinical response and clinical and endoscopic remission outcomes among patients treated with vedolizumab.

Figure 6

Influence of proton pump inhibitor therapy in smokers and non-smokers treated with vedolizumab: (a,b) clinical response at weeks 14 and 54; (c,d) clinical remission at weeks 14 and 5; (e,f) endoscopic remission at weeks 14 and 54; black bar: patients without PPI; grey bar: patients with PPI.

Figure 7

Patients receiving steroid treatment stratified by proton pump inhibitor co-treatment: (a,b) clinical response at weeks 14 and 54; (c,d) clinical remission at weeks 14 and 5; (e,f) endoscopic remission at weeks 14 and 54; black bar: patients without PPI; grey bar: patients with PPI.